In this podcast, we interviewed Jim McGorry, CEO and Saverio LaFrancesca, President and Chief Medical Officer about how Biostage is using cell therapy to improve the standard of care in adult and pediatric esophageal disease…

Vero cells are a monkey kidney cell line that has been a relative constant in the vaccine industry for over 3 decades. These cells have a long and successful history of safe vaccine production for many human and animal vaccines including polio, rotavirus, and smallpox. Vero cells are also a favored cell factory for the production of herpes, measles, and vaccinia-based viral vectors…

Adenovirus-based vectors are commonly-used gene delivery vehicles, especially in gene therapy applications where their efficient nuclear entry mechanism and low pathogenicity for humans are much-valued attributes. In addition, Adenovirus vectors can be produced in high titers and the particles are stable yet easy to modify…

QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed that links material attributes and process parameters to CQAs. By understanding the impact of process parameters on CQAs a design space can be developed in which CQAs will be met. Bioprocess engineers must then implement a suitable control strategy that ensure the process operates with the design space. Continuous improvement activities can be performed throughout the product lifecycle and enhance product quality still further…

Continuous manufacturing has been established in several processing industries for many years, providing many benefits over batch manufacturing. The feasibility of continuous processing has now been shown for monoclonal antibodies (mAb) at both the process development (PD) and the production scales by early adopters…

Significant advances in analytical technology over the past few years have improved the quantification and characterization capabilities for subvisible ( 1 – 100 µm) and submicron particles (≤1 µm). As the technology continues to improve so do the expectations of regulatory agencies for sponsors to characterize particles in these size ranges. However, multiple orthogonal methods are required to span the entire range and accurately characterize the particle profile. Each instrument has its own limitations based on detection method and properties of therapeutic protein products that must be well understood to generate high quality data. KBI Biopharma has extensive experience with particle detection methods, as well as, in-depth particle data analysis. KBI’s Particle Characterization Core team can help choose appropriate orthogonal particle to combine in order to accurately quantify, characterize and identify particles in specific therapeutic protein products for all size ranges based on clients’ needs

Multiple buffers in a wide range of formulations are required to produce a single biopharmaceutical. Because of the large volumes required, buffer preparation can easily become a bottleneck in production. Traditionally, buffers are prepared manually in the volume needed according to specific recipes. Due to the large quantities used, buffer management requires careful planning and considerable floor space is required for the preparation and storage of such large buffer quantities. In addition to high labor and facility space cost, there is a risk of human error and variability associated with such a time-intensive manual activity. Buffer variability can affect both quantity and quality of the final product…

A primary concern limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments. Experimental findings and insights from execution of both the BPOG and USP <665> extractables protocols on multiple single-use components will be shared, including similarities and differences in extraction profiles. Case studies will also be presented illustrating how Pall’s growing portfolio of BPOG extractables datasets can be used to help support component qualification and overall toxicological risk assessment for single-use systems.

Mark Pagkaliwangan presents on July 18th at 1PM EDT, with David Johnson moderating, as they discuss MCC solution advances with processes utilizing two columns or more. They will explore how the total number of columns used in a process can affect performance, and how titer and flowrate can be optimized with more columns for greater efficiency and productivity.

Headlines:

“Repligen said today it plans to merge with privately-held Spectrum Laboratories, in an approximately $359 million deal that Repligen said will accelerate the growth of its filtration business and enhance its position as a leading developer of single-use and continuous-manufacturing technologies for bioprocessing…”

“At a Senate hearing on President Donald Trump’s FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release “modern and risk-based” tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments…”

“Low-density lipoprotein (LDL) is commonly called “bad cholesterol” because it builds up along the walls of the arteries, forming plaques that can cause deadly blockages. But what if a key player in that inflammatory, plaque-building process also had the ability to switch roles, opening up and healing the arteries instead of blocking them?”

“Biological E. (BE) negotiated two licensing agreements with Takeda for the latter’s measles and pertussis vaccines, which will allow BE to develop and commercialize affordable combination vaccines in India, China, and low- and middle-income countries. Takeda has sold both the vaccines in Japan for more than 20 years…”

“Roche’s investigational haemophilia drug emicizumab cut the bleed rate by 87 percent in patients who had developed resistance to standard treatment, compared with those who instead got bypassing agents, the Swiss company said on Monday…”